Periodic mobile application (eMOM) with self-tracking of glucose and lifestyle improves treatment of diet-controlled gestational diabetes without human guidance: a randomized controlled trial - 09/04/24
, Shinji Hotta, MInf c, d, Sari Niinistö, PhD e, Pekka Marttinen, PhD c, Tuuli E. Korhonen, MSc e, Lisa T. Markussen, MSc b, Giulio Jacucci, PhD f, Harri Sievänen, PhD g, Henri Vähä-Ypyä, MSc g, Ilkka Korhonen, PhD h, Suvi Virtanen, PhD e, i, j, k, Seppo Heinonen, PhD b, Saila B. Koivusalo, PhD lAbstract |
Background |
Digitalization with minimal human resources could support self-management among women with gestational diabetes and improve maternal and neonatal outcomes.
Objective |
This study aimed to investigate if a periodic mobile application (eMOM) with wearable sensors improves maternal and neonatal outcomes among women with diet-controlled gestational diabetes without additional guidance from healthcare personnel.
Study Design |
Women with gestational diabetes were randomly assigned in a 1:1 ratio at 24 to 28 weeks’ gestation to the intervention or the control arm. The intervention arm received standard care in combination with use of the periodic eMOM, whereas the control arm received only standard care. The intervention arm used eMOM with a continuous glucose monitor, an activity tracker, and a food diary 1 week/month until delivery. The primary outcome was the change in fasting plasma glucose from baseline to 35 to 37 weeks’ gestation. Secondary outcomes included capillary glucose, weight gain, nutrition, physical activity, pregnancy complications, and neonatal outcomes, such as macrosomia.
Results |
In total, 148 women (76 in the intervention arm, 72 in the control arm; average age, 34.1±4.0 years; body mass index, 27.1±5.0 kg/m2) were randomized. The intervention arm showed a lower mean change in fasting plasma glucose than the control arm (difference, −0.15 mmol/L vs −2.7 mg/mL; P=.022) and lower capillary fasting glucose levels (difference, −0.04 mmol/L vs −0.7 mg/mL; P=.002). The intervention arm also increased their intake of vegetables (difference, 11.8 g/MJ; P=.043), decreased their sedentary behavior (difference, −27.3 min/d; P=.043), and increased light physical activity (difference, 22.8 min/d; P=.009) when compared with the control arm. In addition, gestational weight gain was lower (difference, −1.3 kg; P=.015), and there were less newborns with macrosomia in the intervention arm (difference, −13.1 %; P=.036). Adherence to eMOM was high (daily use >90%), and the usage correlated with lower maternal fasting (P=.0006) and postprandial glucose levels (P=.017), weight gain (P=.028), intake of energy (P=.021) and carbohydrates (P=.003), and longer duration of the daily physical activity (P=.0006). There were no significant between-arm differences in terms of pregnancy complications.
Conclusion |
Self-tracking of lifestyle factors and glucose levels without additional guidance improves self-management and the treatment of gestational diabetes, which also benefits newborns. The results of this study support the use of digital self-management and education tools in maternity care.
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Key words : continuous glucose monitoring, diet, digital health intervention, gestational diabetes, mobile application, physical activity, randomized controlled trial, self-management
Plan
| I.K. reports previously being employed by and a shareholder of Firstbeat Technologies from 2017 to 2022. A patent is planned for the eMOM application; beneficiaries are the project participants (Helsinki University Hospital, Aalto University, Helsinki University, Elisa Oyj, and Fujitsu Finland). |
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| Business Finland, under grant number 860/31/2018, supported Helsinki University Hospital, Aalto University, University of Helsinki, and Fujitsu Finland. The funder of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. |
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| This trial was registered with ClinicalTrials.gov under identifier NCT04714762 on January 15, 2021, and the date of initial participant enrollment was March 10, 2021. |
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| The findings of this study was presented at the 54th annual meeting of the Diabetic Pregnancy Study Group, Madrid, Spain, September 8–10, 2022. |
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| The pseudo-anonymized data sets generated and/or analyzed during this study are available from the corresponding author upon reasonable request from publication until December 2028. Other available documents include the study protocol with statistical analysis plan, data analysis code, and patient consent form. |
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| During the preparation of this work, the authors used ChatGPT v.3.5 to improve language and readability. After using this service, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication. |
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| Cite this article as: Kytö M, Hotta S, Ninistö S, et al. Periodic mobile application (eMOM) with self-tracking of glucose and lifestyle improves treatment of diet-controlled gestational diabetes without human guidance: a randomized controlled trial. Am J Obstet Gynecol 2024;XX:x.ex–x.ex. |
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